Presentation at National Academies of Sciences Engineering Medicine

Transcription

1 FOCUSED ON ADDICTION Presentation at National Academies of Sciences Engineering Medicine 11 th October 2017

2 COI statement Full time employee of Opiant Pharmaceuticals Inc. Shareholder of Opiant Pharmaceuticals Inc. 2

3 Opiant is a specialty pharma focused on addiction Based in Santa Monica, CA & clinical operations in London, UK Company has single focus on developing pharmacotherapies for addiction Particular expertise with opioid antagonists Company origins in Finland 3

4 Lead Programs Indication Product Candidate / Regulatory Pathway Preclinical Phase 1 Phase 2 Phase 3 NDA FDA Approval Partner Opioid Overdose NARCAN Nasal Spray 505(b)(2) Eating Disorders OPNT001 Opioid Antagonist Nasal Spray 505(b)(2) Alcohol Dependence OPNT002 Opioid Antagonist Nasal Spray / 505(b)(2) Opioid Use Disorder OPNT006 Opioid Antagonist Implant Opioid Use Disorder OPNT 005 Heroin hapten + liposome adjuvant 4

5 Opioid addiction and overdose: A significant public health crisis Opioid overdose deaths have increased dramatically since 2000 Opioid often used first for pain relief - reverse ladder of elsewhere USA direct to consumer marketing and (mis)marketing to Drs Drs reimbursed for pain free patients (Medicaid, pain as vital sign..) Dramatic increase in synthetic opioids including fentanyl Approximately opioid 33,000 overdose deaths in

6 And it s getting worse.53,000 deaths in 2016 Graph from NY Times Article based on CDC MMWR Report 2017

7 NEW YORK TIMES, 25 MARCH 2016

8 Fentanyl is more potent than heroin, cheap and very accessible Gets into brain quickly; longer duration of action than heroin x more potent than morphine Easier to produce than heroin Cheaper estimated wholesale price of heroin is $65,000/kg. Illicit fentanyl is available for $13,000/kg (Frank & Pollack, NEJM) Easier to manufacture and further modify into more potent analogs: Synthesis not beyond the skills of a competent chemist Fentanyl is a piperidine - readily derivatized for example into carfentanil

9 Opioid Overdoses Have Reduced Life Expectancy In The USA From Dowell, et al., JAMA,

10 Naloxone saves lives if given quickly injections can only be given by qualified personnel Opioid pain killers, heroin, or fentanyl: victim unresponsive(± breathing) Dial 911 Await ambulance Patient already stopped breathing Help often arrives too late 10

11 Prior to NARCAN Nasal Spray, naloxone options often involved needles, were hard to use and expensive Injectable Naloxone Autoinjectors Improvised Nasal Kits Only suitable for trained personnel Requires prep time Requires a needle Expensive Not needle free Only suitable for trained personnel Requires assembly Not FDA-approved Low absorption 11

12 Concept of Nasal Naloxone first arose from improvised kits

13 PK profile of improvised device device would not meet FDA standard for approval Morrone, J. Addict. Dis. 2016

14 FDA guidance on novel naloxone products FDA advisory committee Oct 2016 recommend a higher dose of a naloxone as a new minimum

15 Opiant partnered with NIDA in 2012, recognizing the potential magnitude of the opioid crisis Alarming data in exposed late 2011: More deaths from OOD than Road Traffic Accidents Widespread prescribing of opioids unique to USA: Meanwhile, Opiant had generated encouraging Phase 2 data using nasal naloxone for Binge Eating Disorder.. Opiant (then Lightlake Therapeutics), established a Clinical Trial Agreement with NIDA in Pilot pk data very encouraging Larger confirmatory pk study established with NIDA in

16 NARCAN Nasal Spray was born out of the need to provide a simple-to-use needle-free solution Key product requirements Opiant s solution Avoidance of needles: people more willing and able to use Capable of reversing overdose from more potent opioids Reliable drug delivery: multidirectional, avoids priming and suited for mass production Easy to use no assembly required suitable for anyone to use with no/minimal training Nasal delivery Higher 4mg dose in novel formulation Aptar Unit dose device 16

17 NARCAN Nasal Spray: both doses: rapid absorption with higher blood levels compared to 0.4mg IM naloxone Naloxone Concentration (ng/ml) 6.0 Dose 1 4mg Intranasal 5.0 Dose 2 2mg Intranasal 4.0 Dose 3 0.4mg Intramuscular Time Post Administration (hour) 17

18 4mg Nasal Naloxone Can Displace [11C] Carfentanil From Brain Opioid Receptors Scheinin, et al., in preparation

19 NARCAN Nasal Spray was FDA approved in November 2015 Licensed to Adapt Pharma First on the market in 2016 Both 4mg and 2mg doses approved in USA Approved in Canada 19

20 NARCAN Nasal Spray is becoming the mainstream rescue product across the USA 20

21 Opiant remains committed to developing treatments for OUD and other addictions Additional programs in OUD including 6mth opioid antagonist implant and a heroin vaccine Phase 2 study in Bulimia Alcohol Use Disorder.significant rise in drinking over last decade. Alcohol Use Disorder... The next epidemic 21

22 FOCUSED ON ADDICTION